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Publication numberUS6517916 B1
Publication typeGrant
Application numberUS 09/451,056
Publication dateFeb 11, 2003
Filing dateNov 30, 1999
Priority dateNov 30, 1999
Fee statusPaid
Also published asUS6793879, US7153469, US20020197424, US20050008527, US20060153759
Publication number09451056, 451056, US 6517916 B1, US 6517916B1, US-B1-6517916, US6517916 B1, US6517916B1
InventorsRobert T. Bayer, Brian G. Hoge, David G. Pasternack, William F. Church, James F. Whitaker, Stephen R. Everson
Original AssigneeAllegiance Corporation
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Four edge sealed sterilization wrap and method for sterilizing an article
US 6517916 B1
Abstract
There is provided an improved sterilization wrap and a method for using the improved sterilization wrap to sterilize an article. The wrap is made of a first and second sheets of sterilization material. Each sheet has first, second, third and fourth edges. Each sheet includes a central portion. The first edge of the first sheet is in register with and bonded to the first edge of the second sheet; the second edge of the first sheet is in register with and bonded to the second edge of the second sheet; the third edge of the first sheet is in register with and bonded to the third edge of the second sheet; and the fourth edge of the first sheet is in register with and bonded to the fourth edge of the second sheet. The central portions of the first and second sheets are substantially not bonded together. Thus, two layers of sterilization material is provided for an article to be sterilized.
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Claims(15)
What is claimed is:
1. A wrapped package formed by the combination of sterilization wrap and an article to be sterilized comprising:
an article to be sterilized; said article to be sterilized being at least one reusable medical instrument;
first and second sheets of sterilization material; each sheet having first, second, third and fourth edges; each sheet having a central portion; said first edge of said first sheet being in register with and bonded to said first edge of said second sheet; said second edge of said first sheet being in register with and bonded to said second edge of said second sheet; said third edge of said first sheet being in register with and bonded to said third edge of said second sheet; said fourth edge of said first sheet being in register with and bonded to said fourth edge of said second sheet; said central portion of said first sheet not substantially bonded to said central portion of said second sheet; said first sheet having an outer surface; said article to be sterilized positioned on said outer surface of said first sheet; said first sheet having an inner surface; said inner surface of said first sheet not contacting said article to be sterilized; said article to be sterilized being wrapped by said first and second sheets, whereby two layers of sterilization material are provided for said article to be sterilized; an open space between said central portions of each sheet, wherein the said open space is substantially sealed by the bonds along said edges of said sheets.
2. A wrapped package as set forth in claim 1, wherein said sterilization material is SMS.
3. A wrapped package as set forth in claim 1, wherein said sterilization material is taken from the group consisting of SMS, two bonded layers of medical grade paper, the combination of medical grade paper, and SMS, the combination of tissue, polyethylene and tissue, and a combination of tissue, polypropylene and tissue.
4. A wrapped package as set forth in claim 1, wherein the adjacent edges of each sheet do not diverge from one another.
5. A wrapped package as set forth in claim 1, wherein said first, second, third and fourth edges of said first sheet are respectively continuously bonded to said first, second, third and fourth edges of said second sheet.
6. A wrapped package formed by the combination of sterilization wrap and an article to be sterilized comprising:
an article to be sterilized; said article to be sterilized being at least one reusable medical instrument;
first and second sheets of sterilization material; each sheet having first, second, third and fourth edges; each sheet having a central portion; said first edge of each sheet being in register and bonded together; said second edge of each sheet being in register and bonded together; said third edge of each sheet being in register and bonded together; said fourth edge of each sheet being in register and bonded together; said first sheet having an outer surface; said article to be sterilized positioned on said outer surface of said first sheet; said first sheet having an inner surface; said inner surface of said first sheet not contacting said article to be sterilized; said article to be sterilized being wrapped by said first and second sheets, whereby two layers of sterilization material are provided for said article to be sterilized; said central portion of said first sheet not substantially bonded to said central portion of said second sheet; an open space between said central portions of each sheet, wherein the said open space is substantially sealed by the bonds along said edges of said sheets, whereby the region between central portions of each sheet is substantially protected from contaminates.
7. A wrapped package as set forth in claim 6, wherein said sterilization material is SMS.
8. A wrapped package as set forth in claim 6, wherein said sterilization material is taken from the group consisting of SMS, two bonded layers of medical grade paper, the combination of medical grade paper, and SMS, the combination of tissue, polyethylene and tissue, and a combination of tissue, polypropylene and tissue.
9. A wrapped package as set forth in claim 6, wherein the adjacent edges of each sheet do not diverge from one another.
10. A wrapped package as set forth in claim 6, wherein said first, second, third and fourth edges of said first sheet are continuously bonded to said respective first, second, third and fourth edges of said second sheet.
11. A wrapped package formed by the combination of sterilization wrap and an article to be sterilized comprising:
an article to be sterilized; said article to be sterilized being at least one reusable medical instrument;
first and second sheets of sterilization material; each sheet having first, second, third and fourth edges; each sheet having a central portion; said first edge of each sheet being in register and bonded together; said second edge of each sheet being in register and bonded together; said third edge of each sheet being in register and bonded together; said fourth edge of each sheet being in register and bonded together; said central portion of each sheet being substantially not bonded together, whereby said edges are readily grasped by the person wrapping the articles to be sterilized; said first sheet having an outer surface; said article to be sterilized positioned on said outer surface of said first sheet; said first sheet having an inner surface; said inner surface of said first sheet not contacting said article to be sterilized; said article to be sterilized being wrapped by said first and second sheets, whereby two layers of sterilization material are provided for said article to be sterilized; an open space between said central portions of each sheet, wherein the said open space is substantially sealed by the bonds along said edges of said sheets.
12. A wrapped package as set forth in claim 11, wherein said sterilization material is SMS.
13. A wrapped package as set forth in claim 11, wherein said sterilization material is taken from the group consisting of SMS, two bonded layers of medical grade paper, the combination of medical grade paper, and SMS, the combination of tissue, polyethylene and tissue, and a combination of tissue, polypropylene and tissue.
14. A wrapped package as set forth in claim 11, wherein the adjacent edges of said sheets do not diverge from one another.
15. A wrapped package as set forth in claim 11, wherein the edges are substantially continuously bonded.
Description
BACKGROUND OF THE INVENTION

This invention relates to sterilization wrap. More particularly, it relates to sterilization wrap having two sheets of sterilization material.

Reusable medical instruments must be sterilized prior to each use. Normally, these instruments are sterilized by steam or ethylene-oxide. In order for the instruments to remain sterile after the sterilization procedure, the instruments must be wrapped in a material called “sterilization wrap”.

The most common type of sterilization wrap is a three-ply laminate consisting of a layer of melt blown polypropylene sandwiched between two layers of spun bond polypropylene. The wrap includes bond points all across the face of the material so that the material is held together, i.e., laminated. This three-ply material is commonly referred to as “SMS”, which is short for spun bond—melt blown—spun bond. Most hospitals specify SMS as the sterilization wrap to be used because SMS is sufficiently porous to permit steam, ethylene-oxide and other sterilization materials to penetrate through the material to the surgical instruments, but has filtration properties sufficient to prevent the passage of most pathogens therethrough and maintain sterility after the sterilization process. The wrap also protects articles during sterilization, and acts as a filtration medium for the sterilant.

In most hospitals, there is a protocol which requires surgical instruments to be wrapped with two separate sheets of SMS so that in the event one sheet becomes torn, there is a redundancy which will maintain the sterility of the surgical instruments. The wrapping of surgical instruments with two separate sheets of sterilization wrap obviously is labor intensive in that the nurse must first place the instruments on one sheet of sterilization material and wrap the instruments, and then place the wrapped package on another sheet of sterilization material and wrap the package containing the instruments.

In an attempt to reduce the labor required to provide dual wrapping of surgical instruments, Kimberly-Clark Corporation has developed a product called “One Step Sterilization Wrap”. One Step Sterilization Wrap is made by bonding two separate sheets of sterilization wrap together near two of the edges of the adjacent sheets. The Kimberly-Clark One Step product is described in U.S. Pat. Nos. 5,635,134 and 5,688,476.

FIG. 1 shows one of the Kimberly-Clark One Step products described in these Kimberly-Clark patents. Sterilization wrap 10 includes a top layer 12 made of SMS and a bottom layer 14 also made of SMS. The two layers of SMS are bonded together near two opposing edges 16 and 18, as illustrated by bond lines 20 and 22. The method of bonding the two sheets together may be ultrasonic bonding. The other two opposing edges 24 and 26 are not bonded together so there is a visible gap 28 between sheets 12 and 14 so that the user of the sterilization wrap visually distinguishes the fact that there are, indeed, two sheets. Apparently the purpose for insuring that the two sheets are visually distinguishable as separate sheets is so that the user will know with certainty that the item to be sterilized has two sheet protection. However, because of this gap 28, debris could enter the region between the two sheets. With two of the edges being unbonded, it is possible that the sheets will become misaligned so that if a sharp object penetrates both sheets, the resulting holes in each sheet could also become misaligned, thus reducing ones ability to determine whether or not there is a hole through both sheets. In addition, since edges 24 and 26 are not bonded and bond lines 20 and 22 are somewhat removed from edges 16 and 18, fibers from those edges could become released from the wrap. Also, since the edges 24 and 26 are not bonded, the two sheets might be pulled apart by mistake during use. Furthermore, since the wrap shown in FIG. 1 is not sealed right to the edges 16 and 18, the user might perceive that there could be contamination between the sheets. Thus, there is a need for a sterilization wrap which provides two layers of protection and which overcomes the problems of the prior art.

OBJECTS OF THE INVENTION

It is therefore one object of this invention to provide an improved two-sheet sterilization wrap.

It is another object of this invention to provide a two-sheet sterilization wrap which is easy to use.

It is still another object of this invention to provide an improved two-sheet sterilization wrap which is less likely to be contaminated and is less likely to be pulled apart.

It is yet another object of this invention to provide a method for sterilizing an article utilizing an improved two-sheet sterilization wrap.

It is still another object of this invention to provided a two sheet sterilization wrap which eliminates confusion by the user regarding the number of sheets in each wrap.

SUMMARY OF THE INVENTION

In accordance with one form of this invention, there is provided a sterilization wrap made from two sheets of sterilization material. Each sheet has first, second, third and fourth edges. Each sheet includes a central portion. The first edge of the first sheet is in register with and bonded to the first edge of the second sheet. The second edge of the first sheet is in register with and bonded to the second edge of the second sheet. The third edge of the first sheet is in register with and bonded to the third edge of the second sheet. The fourth edge of the first sheet is registered with and bonded to the fourth edge of the second sheet. The central portions of each sheet are substantially not bonded together. Thus two layers of sterilization material is provided for the article to be sterilized. The region between the central portion of each sheet is protected from contaminates and the bonded edges of the wrap are readily grasped by the person wrapping the articles to be sterilized.

In accordance with another form of this invention, there is provided a method for sterilizing an article, including the step of providing the article, wrapping the article with sterilization wrap made in accordance with the above-described design, and applying sterilization conditions to the wrapped article.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter which is regarded as the invention is set forth in the appended claims. The invention itself, however, together with further objects and advantages thereof may be better understood in reference to the accompanying drawings in which:

FIG. 1 is a perspective view of a prior art sterilization wrap;

FIG. 2 is a perspective view of the sterilization wrap, in accordance with this subject invention;

FIG. 3 is a sectional view of the sterilization wrap of FIG. 2 taken through Section Lines 33;

FIG. 4 is sectional view of the sterilization wrap of FIG. 2 taken through Section Lines 44;

FIG. 5 is a plan view of the sterilization wrap of FIG. 2 showing the materials to be sterilized in preparation for wrapping.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now more particularly to FIGS. 2 through 5, there is provided a sterilization wrap in the form of application 30 which is made of two sheets of sterilization material 32 and 34. Each sheet of sterilization material is preferably a three ply laminate having a layer of melt blown polypropylene sandwiched between two layers of spun bonded polypropylene, referred to as SMS. SMS is commercially available from BBA Nonwovens Company. Alternatively, each sheet could be made of two bonded layers of medical grade paper CSR, a combination of paper CSR and SMS, a combination of tissue, polyethylene (or polypropylene) and tissue, and other known sterilization materials.

Sheet 32 is the same size as sheet 34, and the two sheets are in register with one another and are joined together by bonding the two sheets along all four of their respective edges, as illustrated by bond points 36.

As shown in FIG. 3, edge 38 of sheet 32 is bonded to edge 40 of sheet 34. Edge 42 of sheet 32 is bonded to edge 44 of sheet 34. As shown in FIG. 4, edge 46 of sheet 32 is bonded to edge 48 of sheet 34. Edge 50 of sheet 32 is bonded to edge 52 of sheet 34. The central region 54 of sheet 32 in not substantially bonded to the central region 56 of sheet 34. This results in open space 58 occurring between sheet 32 and sheet 34.

The bond points 36 along the edges of each sheet are preferably at the very end of the edges of each sheet. This will substantially reduce the likelihood that fibers from free edges will be released since the bonding process melts the fibers at the bond points. The bond points illustrated in FIG. 2 show the bond points spaced apart for illustrative purposes only. Actually, the bond points are very close together.

The central region 54 of sheet 32 and central region 56 of sheet 34 remain substantially not bonded together so that the passage of the sterilization materials through the wrap to the articles 60 to be sterilized is not substantially reduced by the points. That is, thermal bonding of the two sheets together in their central regions 54 and 56 will melt the SMS, resulting in a film like structure which would block the passage of a substantial amount of ethylene oxide or steam, which are the preferred sterilization materials.

Since the sterilization wrap is bonded along all four edges, the wrap will not be visually distinguishable as two separate sheets. However, a significant advantage of the two sheets being bonded together along all four edges is the fact that debris will not be permitted to penetrate into the open space 58 since all four edges, in effect, are sealed. In addition, since the bonding occurs directly adjacent to the edges, or even overlapping the edges, loss of fibers about the edges is substantially reduced. Furthermore, since all four edges are bonded together, the likelihood that the two sheets will stay together is substantially enhanced. Also, since the bond of all four edges occurs directly adjacent to the edges, there should be no user perception that there might be contamination between the sheets and/or that the sterilization materials might escape.

The sterilization wrap of the subject invention, with the two sheets bonded together on the edges, also provides a reasonable rigid edge which is easily grasped by the person using the sterilization wrap.

One of the methods of bonding is ultrasonic bonding which results in bond points. Alternatively, hot melt glue, a heated knife or wire, laser, water jet, thermo-mechanism, or mechanical embossing may be used to create the bonding.

The sterilization wrap of the subject invention is easy to manufacture. Two identical size sheets are cut into the desired shape, most commonly square shape. The two sheets are placed in register, and then all four edges are bonded together by one of the bonding techniques referred to above.

By utilizing this invention, there is no need for the user to handle two separate sheets of sterilization wrap in order to provide two layers of protection for the articles to be sterilized. A single application 30 is removed from its container and placed flat on a table. The article to be sterilized is placed in the center of the wrap/application 30. The article is then wrapped in the generally prescribed or acceptable fashion. The wrapped article is placed in an autoclave or gas enclosure and is subjected to sterilizing conditions.

From the foregoing description of the preferred embodiments of the invention, it will be apparent that many modifications may be made therein. It will be understood, however, that the embodiments of the invention are an exemplification of the invention only and that the invention is not limited thereto. It is to be understood, therefore, that it is intended in the appended claims to cover all modifications as fall within the true spirit and scope of the invention.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3761013Mar 20, 1972Sep 25, 1973Schuster SDouble wall package for storing items in bacteria-free condition
US3780857Dec 30, 1971Dec 25, 1973Band C R IncInstrument package with sterile field
US4196245Jun 16, 1978Apr 1, 1980Buckeye Cellulos CorporationComposite nonwoven fabric comprising adjacent microfine fibers in layers
US4201031Sep 27, 1978May 6, 1980Rexham CorporationMethod of making, opening, filling and sealing a two-compartment pouch
US4342392Sep 10, 1979Aug 3, 1982The Buckeye Cellulose CorporationWrap for sterile articles
US4581874Jul 14, 1983Apr 15, 1986Franrica Mfg. Inc.Apparatus and methods for filling and sealing an aseptic fitmentless pouch
US4644586Oct 25, 1984Feb 17, 1987Kimberly-Clark CorporationCombination sterilization and infectious waste disposal container
US4644732Aug 8, 1985Feb 24, 1987Lumo, Inc.Easy opening, disposable condiment container
US4863785Nov 18, 1988Sep 5, 1989The James River CorporationNonwoven continuously-bonded trilaminate
US5072832Feb 6, 1990Dec 17, 1991Devon Industries, Inc.Multipurpose shaped pitcher and surgical kit and wrap system
US5635134Jun 6, 1995Jun 3, 1997Kimberly-Clark CorporationWrapping the medical equipment with a sterilization wrap which consists of inner and outer wrap sheets and exposing the equipment for sufficient time for sterilizion by steam or by ethylene oxide; one step
US5673541Oct 31, 1995Oct 7, 1997Emplex Systems, Inc.Apparatus and method for forming, filling and sealing a bag
US5681646 *Apr 19, 1996Oct 28, 1997Kimberly-Clark Worldwide, Inc.High strength spunbond fabric from high melt flow rate polymers
US5683795 *Apr 15, 1994Nov 4, 1997Kimberly-Clark Worldwide, Inc.Gamma irradiated aseptically tieable gown
US5688476Nov 14, 1996Nov 18, 1997Kimberly Clark CorporationSingle step sterilization wrap system
US5879620Nov 13, 1997Mar 9, 1999Kimberly-Clark Worldwide, Inc.Inner wrap and reusable outer bag of breathable, nonwoven material
US6406764May 18, 1998Jun 18, 2002American Threshold Industries, Inc.Two-ply sterilization wrap and method for sterilizing an article
GB1488326A Title not available
WO1992005074A1Sep 24, 1991Apr 2, 1992Ahlstroem Consumer ProdA sterile web, to be used to wrap sterile medical articles, and a method to produce the web
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7560082Oct 13, 2004Jul 14, 2009Allegiance CorporationSterilization wraps and methods for sterilizing articles
US7718433Oct 21, 2004May 18, 2010Allegiance CorporationPackaging system for a sterilized article
US7906070Jun 11, 2009Mar 15, 2011Allegiance CorporationSterilization wraps and methods for sterilizing articles
US20090246079 *Jun 11, 2009Oct 1, 2009Allegiance CorporationSterilization wraps and methods for sterilizing articles
US20120234333 *Mar 16, 2011Sep 20, 2012Jenkins Shawn EMedical Fabric With Asymmetrical Layers
EP2077096A1Aug 10, 2005Jul 8, 2009Kimberly-Clark Worldwide, Inc.Multiple ply sterilization wrap
Classifications
U.S. Classification428/34.3, 422/294, 206/439, 428/35.2, 428/35.7, 428/192, 428/36.1, 383/102
International ClassificationD04H5/08, A61L2/26, D04H13/00, B32B7/08, A61B19/02
Cooperative ClassificationD04H5/08, A61L2202/181, A61B19/0262, D04H13/002, A61L2/26, A61L2202/24, B32B7/08
European ClassificationA61B19/02P2, D04H13/00B2, D04H5/08, B32B7/08, A61L2/26
Legal Events
DateCodeEventDescription
Aug 11, 2010FPAYFee payment
Year of fee payment: 8
Jun 28, 2010ASAssignment
Free format text: NUNC PRO TUNC ASSIGNMENT;ASSIGNOR:CARDINAL HEALTH 200, INC.;REEL/FRAME:24599/395
Effective date: 20090601
Owner name: ALLEGIANCE CORPORATION,ILLINOIS
Free format text: NUNC PRO TUNC ASSIGNMENT;ASSIGNOR:CARDINAL HEALTH 200, INC.;REEL/FRAME:024599/0395
Aug 11, 2006FPAYFee payment
Year of fee payment: 4
May 16, 2003ASAssignment
Owner name: CARDINAL HEALTH 200, INC., OHIO
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ALLEGIANCE CORPORATION;REEL/FRAME:014066/0816
Effective date: 20030422
Owner name: CARDINAL HEALTH 200, INC. 7000 CARDINAL PLACEDUBLI
Dec 2, 2002ASAssignment
Owner name: ALLEGIANCE CORPORATION, ILLINOIS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:AMERICAN THRESHOLD INDUSTRIES, INC.;REEL/FRAME:013543/0427
Effective date: 20021121
Owner name: ALLEGIANCE CORPORATION 1430 WAUKEGAN ROADMCGAW PAR
Mar 26, 2001ASAssignment
Owner name: AMERICAN THRESHOLD INDUSTRIES, INC., NORTH CAROLIN
Free format text: CORRECTED RECORDATION FORM COVER SHEET TO CORRECT TYPOGRAPHICAL ERROR IN THE PREVIOUS DEED OF ASSIGNMENT WHICH WAS RECORDED AT REEL/FRAME 010427/0646, WHEREIN THE STATE OF INCORPORATION WAS INCORRECTLY STATED TO BE NORTH CAROLINA. THE CORRECT STATE OF INCORPORATION IS GEORGIA.;ASSIGNORS:BAYER, ROBERT T.;HOGE, BRIAN G.;PASTERNACK, DAVID G.;AND OTHERS;REEL/FRAME:011666/0073;SIGNING DATES FROM 19991117 TO 19991122
Owner name: AMERICAN THRESHOLD INDUSTRIES, INC. 240 SANDIS ROA
Free format text: CORRECTED RECORDATION FORM COVER SHEET TO CORRECT TYPOGRAPHICAL ERROR IN THE PREVIOUS DEED OF ASSIGNMENT WHICH WAS RECORDED AT REEL/FRAME 010427/0646, WHEREIN THE STATE OF INCORPORATION WAS INCORRECTLY STATED TO BE NORTH CAROLINA. THE CORRECT STATE OF INCORPORATION IS GEORGIA.;ASSIGNORS:BAYER, ROBERT T. /AR;REEL/FRAME:011666/0073;SIGNING DATES FROM 19991117 TO 19991122
Nov 30, 1999ASAssignment
Owner name: AMERICAN THRESHOLD INDUSTRIES, INC., NORTH CAROLIN
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BAYER, ROBERT T.;HOGE, BRIAN G.;PASTERNACK, DAVID G.;ANDOTHERS;REEL/FRAME:010427/0646;SIGNING DATES FROM 19991117 TO 19991122
Owner name: AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS ROA